Evaluation of the Patient-ventilator Asynchrony During Mechanical Ventilation for Pediatric Acute Respiratory Failure (Asynchrony)

May 2, 2017 updated by: Dr Guillaume Emeriaud, St. Justine's Hospital

The synchronization between the patient and the ventilator is an essential objective during mechanical ventilation (MV). Maintaining the patient's respiratory activity during MV reduces ventilation pressures, improves oxygenation, and decreases sedation. In order to do this, the inspiratory or expiratory effort of the patient must be detected by the respirator' sensor systems, so that the assistance delivered by the respirator is coordinated with the patient's respiratory cycles. The usual systems do not actually detect the beginning of the effort but its result: variation in flow rate or pressure at the respirator circuit, which depends on the patient's respiratory mechanics and sensitivity of the sensor. This detection is currently imperfect, which generates asynchrony between the patient's needs and the assistance of the respirator. The asynchrony comprises the periods of delay between the beginning of the inspiration (or expiration) and the response of the respirator, but also of the unsuitable cycles: inspiratory efforts of the patient not detected by the respirator, or inversely triggering assistance in the absence of inspiration by the patient (self-initiation), or delivery of 2 cycles of assistance for a single inspiration (double triggering).

Asynchrony is a risk factor for prolonged mechanical ventilation in adults. Adult studies have shown that patient-ventilator asynchrony is common during MV, and is associated with prolonged MV duration. An association with length of stay in intensive care and in hospital was also observed. In children, patient-ventilator synchronization is more difficult to achieve than in adults due to a higher respiratory rate and smaller current volumes. The impact of patient-ventilator asynchrony on evolution has not been studied in pediatrics.

Patient-ventilator synchronization could be improved by the development of new ventilatory modes. The new NAVA (neurally adjusted ventilatory assist) ventilation mode detects the patient's breathing efforts earlier by monitoring the electrical activity of the diaphragm through the esophagus. This new mode seems to improve synchronization in children. NAVA ventilation may therefore be a step forward, but its clinical benefits remain to be seen.

The objective of this study is to evaluate the impact of patient-ventilator asynchrony on the duration of mechanical ventilation in children with acute respiratory failure.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • St. Justine's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients under mechanical ventilation for acute respiratory failure

Description

Inclusion Criteria:

  • Mechanical ventilation planned for more than 24h according to the physician in charge;
  • Presence of a spontaneous respiratory activity (defined by the presence of respiratory cycles activated by the patient);
  • Parental consent obtained with the parents or with the legal representative.

Exclusion Criteria:

  • pathologies for which a long and difficult weaning of the mechanical ventilation is expected: chronic respiratory failure with history of ventilation superior to one month, severe neurological or muscular pathology;
  • Patients with a tracheotomy;
  • Patients receiving a treatment by curare;
  • Contraindication of recording of the diaphragmatic activity by oesophageal way, in particular recent oesophageal surgery, oesophageal stenosis, suspicion of diaphragmatic paralysis, severe coagulation disorder;
  • Patients to whom a death seems imminent;
  • Patients for whom a limitation of the care was considered.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe patient-ventilator asynchrony
Patients in whom the total percentage of time spent in asynchrony is superior to the entire cohort's 75th percentile
Routine mechanical ventilation in PICU amid children with acute respiratory failure
less severe patient-ventilator asynchrony
Patients in whom the total percentage of time spent in asynchrony is inferior to the entire cohort's 75th percentile
Routine mechanical ventilation in PICU amid children with acute respiratory failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in ventilator free days
Time Frame: 28 days
Difference in ventilator free days at Day 28th between the two patient groups (high versus moderate asynchrony)
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of asynchrony on Comfort scale
Time Frame: at inclusion
Comfort Scale between the two patient groups (high versus moderate asynchrony)
at inclusion
Intensive care unit length of stay
Time Frame: 28 days
between the two patient groups (high versus moderate asynchrony)
28 days
Mortality in pediatric intensive care unit
Time Frame: 28 days
between the two patient groups (high versus moderate asynchrony)
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2010

Primary Completion (Actual)

October 17, 2012

Study Completion (Actual)

January 6, 2017

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUSJ-3113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mechanical Ventilation

Clinical Trials on Routine mechanical ventilation

3
Subscribe